US2025339632A1PendingUtilityA1

Nasal administration

71
Assignee: OPTINOSE INCPriority: Mar 26, 2013Filed: Jul 14, 2025Published: Nov 6, 2025
Est. expiryMar 26, 2033(~6.7 yrs left)· nominal 20-yr term from priority
A61M 16/1055A61M 16/107A61M 11/003A61M 15/0041A61M 2202/0468A61M 15/0098A61M 2205/3324A61M 2205/3334A61M 2202/064A61M 2202/0275A61M 2202/0225A61M 16/20A61M 16/14A61M 16/0057A61M 16/0045A61M 15/009A61M 15/0021A61M 15/08
71
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Claims

Abstract

A method of delivering a substance, such as one or more of a triptan, a nasal steroid or carbon dioxide gas, to the nasal cavity of a subject, in particular for the treatment of headaches, for example, migraine, or rhinosinusitis, for example, chronic rhinosinusitis, optionally with polyps, the method comprising the steps of fitting a nosepiece to one nostril of the subject, delivering the substance through the nosepiece to the posterior region of the nasal cavity of the subject.

Claims

exact text as granted — not AI-modified
1 .- 80 . (canceled) 
     
     
         81 . A method of treating nasal polyps in a patient comprising:
 placing a nosepiece of a housing into a first nostril of the patient;   placing a mouthpiece of the housing into a mouth of the patient, the mouthpiece being fluidly connected to the nosepiece by a flow path, wherein exhalation by the patient into the mouthpiece and out of the nosepiece produces a bi-directional fluid flow of exhalation air into a first nasal passageway of the patient and out of a second nasal passageway of the patient;   manually depressing a chamber with the patient's thumb or finger to activate a pump and flow fluticasone from the chamber to the nosepiece;   opening a valve in the flow path from the mouthpiece to the nosepiece in response to manually depressing the chamber;   administering fluticasone during exhalation by the patient through the nosepiece;   delivering carbon dioxide during exhalation by the patient through the nosepiece, to a location at an upper posterior region of the first nasal passageway of the patient; and   reducing a pH at the location at the upper posterior region of the first nasal passageway of the patient by an amount ranging from about 0.1 pH units to about 0.2 pH units by controlling the fluid flow to deliver the carbon dioxide at a concentration of from about 5% vol/vol to about 6% vol/vol carbon dioxide and at a fluid flow rate of at least 20 L/min for a duration of from about 2 seconds to about 3 seconds, wherein the carbon dioxide is delivered before or at the same time as the fluticasone.   
     
     
         82 . The method of  claim 81 , wherein the fluticasone is fluticasone propionate. 
     
     
         83 . The method of  claim 81 , wherein the fluticasone is administered as a liquid aerosol. 
     
     
         84 . The method of  claim 81 , wherein the fluticasone is administered in an amount of about 400 μg b.i.d. 
     
     
         85 . The method of  claim 81 , wherein the fluticasone is administered in an amount of 100 μg to 400 μg b.i.d. 
     
     
         86 . The method of  claim 81 , wherein the fluticasone is administered in an amount of at least 400 μg daily. 
     
     
         87 . The method of  claim 81 , wherein the fluticasone is administered in an amount of at least 400 μg daily delivered in two doses. 
     
     
         88 . The method of  claim 81 , wherein the fluticasone is fluticasone propionate administered as a liquid aerosol in an amount of 100 μg to 400 μg b.i.d. 
     
     
         89 . The method of  claim 81 , wherein the fluticasone is fluticasone propionate administered as a liquid aerosol in an amount of at least 200 μg b.i.d. 
     
     
         90 . The method of  claim 81 , wherein the chamber, pump and nosepiece are axially aligned. 
     
     
         91 . The method of  claim 81 , further comprising flowing the fluticasone through a nozzle proximate the nosepiece during exhalation by the patient. 
     
     
         92 . The method of  claim 81 , wherein the administering of the fluticasone further comprises simultaneously delivering the fluticasone and exhalation air to the first nasal passageway. 
     
     
         93 . The method of  claim 81 , wherein the manually depressing of the chamber further comprises axially moving the chamber within an aperture in the housing. 
     
     
         94 . The method of  claim 81 , further comprising flowing the exhalation air through a delivery channel of the flow path that extends from the valve towards the nosepiece. 
     
     
         95 . The method of  claim 94 , wherein the delivery channel inwardly tapers as the delivery channel extends from the valve towards the nosepiece. 
     
     
         96 . A method of treating chronic rhinosinusitis with or without nasal polyps in a patient comprising:
 placing a nosepiece of a housing into a first nostril of the patient;   placing a mouthpiece of the housing into a mouth of the patient, the mouthpiece being fluidly connected to the nosepiece by a flow path, wherein exhalation by the patient into the mouthpiece and out of the nosepiece produces a bi-directional fluid flow of exhalation air into a first nasal passageway of the patient and out of a second nasal passageway of the patient;   manually depressing a chamber with the patient's thumb or finger to activate a pump and flow fluticasone from the chamber to the nosepiece;   opening a valve in the flow path from the mouthpiece to the nosepiece in response to manually depressing the chamber;   administering fluticasone during exhalation by the patient through the nosepiece;   delivering carbon dioxide during exhalation by the patient through the nosepiece, to a location at an upper posterior region of the first nasal passageway of the patient; and   reducing a pH at the location at the upper posterior region of the first nasal passageway of the patient by an amount ranging from about 0.1 pH units to about 0.2 pH units by controlling the fluid flow to deliver the carbon dioxide at a concentration of from about 5% vol/vol to about 6% vol/vol carbon dioxide and at a fluid flow rate of at least 20 L/min for a duration of from about 2 seconds to about 3 seconds, wherein the carbon dioxide is delivered before or at the same time as the fluticasone.   
     
     
         97 . The method of  claim 96 , wherein the fluticasone is fluticasone propionate. 
     
     
         98 . The method of  claim 96 , wherein the fluticasone is administered as a liquid aerosol. 
     
     
         99 . The method of  claim 96 , wherein the fluticasone is administered in an amount of about 400 μg b.i.d. 
     
     
         100 . The method of  claim 96 , wherein the fluticasone is administered in an amount of 100 μg to 400 μg b.i.d. 
     
     
         101 . The method of  claim 96 , wherein the fluticasone is administered in an amount of at least 400 μg daily. 
     
     
         102 . The method of  claim 96 , wherein the fluticasone is administered in an amount of at least 400 μg daily delivered in two doses. 
     
     
         103 . The method of  claim 96 , wherein the fluticasone is fluticasone propionate administered as a liquid aerosol in an amount of 100 μg to 400 μg b.i.d or in an amount of at least 200 μg b.i.d. 
     
     
         104 . The method of  claim 96 , wherein the chamber, pump and nosepiece are axially aligned. 
     
     
         105 . The method of  claim 96 , further comprising flowing the fluticasone through a nozzle proximate the nosepiece during exhalation by the patient. 
     
     
         106 . The method of  claim 96 , wherein the administering of the fluticasone further comprises simultaneously delivering the fluticasone and exhalation air to the first nasal passageway. 
     
     
         107 . The method of  claim 96 , wherein the manually depressing of the chamber further comprises axially moving the chamber within an aperture in the housing. 
     
     
         108 . The method of  claim 96 , further comprising flowing the exhalation air through a delivery channel of the flow path that extends from the valve towards the nosepiece. 
     
     
         109 . The method of  claim 108 , wherein the delivery channel inwardly tapers as the delivery channel extends from the valve towards the nosepiece. 
     
     
         110 . A method of treating chronic rhinosinusitis with or without nasal polyps in a patient comprising:
 placing a nosepiece of a housing into a first nostril of the patient;   placing a mouthpiece of the housing into a mouth of the patient, the mouthpiece being fluidly connected to the nosepiece by a flow path, wherein exhalation by the patient into the mouthpiece and out of the nosepiece produces a bi-directional fluid flow of exhalation air into a first nasal passageway of the patient and out of a second nasal passageway of the patient;   manually depressing a chamber with the patient's thumb or finger to activate a pump and flow fluticasone from the chamber to the nosepiece,
 wherein the manually depressing of the chamber further comprises axially moving the chamber within an aperture in the housing; 
   opening a valve in the flow path from the mouthpiece to the nosepiece in response to manually depressing the chamber;   administering fluticasone during exhalation by the patient through the nosepiece;   delivering carbon dioxide during exhalation by the patient through the nosepiece, to a location at an upper posterior region of the first nasal passageway of the patient; and   reducing a pH at the location at the upper posterior region of the first nasal passageway of the patient by an amount ranging from about 0.1 pH units to about 0.2 pH units by controlling the fluid flow to deliver the carbon dioxide at a concentration of from about 5% vol/vol to about 6% vol/vol carbon dioxide and at a fluid flow rate of at least 20 L/min for a duration of from about 2 seconds to about 3 seconds, wherein the carbon dioxide is delivered before or at the same time as the fluticasone, wherein:
 the chamber, pump and nosepiece are axially aligned; 
 the flow path includes a delivery channel which inwardly tapers as the delivery channel extends from the valve towards the nosepiece; and 
 the administering of the fluticasone further comprises simultaneously delivering the fluticasone and exhalation air towards the first nasal passageway.

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